Field of the Invention
The present invention generally relates to systems, devices and methods for inserting biomedical implants, and more particularly, to systems, devices and methods for accurately positioning biomedical implants in tissue.
Description of the Related Art
Women account for more than 11 million incontinence cases, with many of those women suffering from stress urinary incontinence (SUI). Women with SUI involuntarily lose urine during normal daily activities and movements, such as laughing, coughing, sneezing and regular exercise.
SUI may be caused by a functional defect or weakened tissue or ligaments connecting the vaginal wall with the pelvic muscles and pubic bone. Common causes include repetitive straining of the pelvic muscles, childbirth, loss of pelvic muscle tone, and estrogen loss. Such a defect results in an improperly functioning urethra. Unlike other types of incontinence, SUI is not a problem of the bladder.
Normally, the urethra, when properly supported by strong pelvic floor muscles and healthy connective tissue, maintains a tight seal to prevent involuntary loss of urine. When a woman suffers from the most common form of SUI, however, weakened muscle and pelvic tissues are unable to adequately support the urethra in its correct position. As a result, during normal movements when pressure is exerted on the bladder from the diaphragm, the urethra cannot retain its seal, permitting urine to escape. Because SUI is both embarrassing and unpredictable, many women with SUI avoid an active lifestyle and shy away from social situations.
One device and method for treating female urinary stress incontinence is described in detail in U.S. Pat. No. 5,899,909, which is incorporated herein by reference in its entirety. The '909 patent discloses a surgical instrument comprising a shank having a handle at one end and connecting means at the other end to receive, one at a time, two curved needle-like elements which each are connected at one end to respective ends of a mesh intended to be implanted into the body. In practice, the mesh is passed into the body via the vagina first at one end and then at the other end, at one side and the other, respectively, of the urethra to form a loop around the urethra, located between the urethra and vaginal wall. The mesh is extended over the pubis and through the abdominal wall and is tightened. The mesh ends are cut at the abdominal wall, and the mesh is left implanted in the body. This trans-vaginal procedure is exemplified by the TVT product sold by Ethicon Inc., a Johnson & Johnson Company, of Somerville, N.J., USA. In this procedure two 5 mm needles pass a PROLENE mesh trans-vaginally and through the abdomen to create a tension-free support under the mid-urethra.
Sub-urethral slings have also been placed by a different approach wherein a needle is passed first though the abdominal wall along the same path as described above, and eventually exiting through the vaginal incision. The tape is then coupled to the needle in some manner, and pulled back through the body from the vaginal incision and out through the abdominal incision. The chosen approach, vaginal or abdominal, will often depend on the preferences of the surgeon.
Yet another approach for implanting a sub-urethral sling has also been recently developed in which the implanted sling extends from beneath the urethra, and out through the obturator hole on either side. This “transobturator” procedure may involve inserting an appropriately configured needle from a vaginal incision and subsequently out through the obturator hole, or vice versa. The former technique (an “inside-out” approach) and associated instruments are described in detail in U.S. Pat. Nos. 7,611,454, 7,204,802, and 7,261,723, and U.S. Patent Publication No. 2009/0306459, which are incorporated herein by reference in their entirety. As illustrated in U.S. Pat. No. 7,261,723, this technique may be performed using a surgical instrument including a surgical passer or introducer and tube elements applied over the ends of the surgical passers that are coupled to the tape to be implanted under the urethra.
More recently, sub-urethral slings that do not exit the body through the abdominal wall or the buttocks have been developed. These sub-urethral slings are secured inside the body into bone, tissue or the like. One embodiment is described in U.S. Pat. No. 7,285,086, the disclosure of which is hereby incorporated by reference herein.
With sub-urethral slings, proper and accurate positioning of the distal ends within targeted tissue is essential in order to have and maintain the proper amount of support under the urethra to alleviate incontinence. One challenge encountered in achieving this is that the ends of the sling must be coupled to some type of insertion device to be placed in position, then subsequently uncoupled from the insertion device so that the insertion device can be withdrawn leaving the implant in place within the body. Many insertion devices for coupling an implant to the insertion device, however, have no attachment mechanisms, have cumbersome attachment mechanisms, and/or require undesirable forces to be applied to uncouple the implant, which, in turn, frequently moves or dislodges the ends of the implant from the targeted and desired position upon uncoupling.
In one embodiment, commonly assigned U.S. patent application Ser. No. 13/488,664, filed Jun. 5, 2012, now U.S. Pat. No. 9,044,223, the disclosure of which is hereby incorporated by reference herein, teaches an implant insertion system including an implant, such as a surgical mesh, having at least one insertion tip secured to the implant. Each insertion tip has a tapered distal end, a proximal end, a base extending proximally from the tapered distal end, and a central lumen formed in the base having an opening facing the proximal end of the insertion tip. The system includes an insertion device having an outer shaft and a latching assembly provided at a distal end of the outer shaft that is insertable into the opening of the central lumen for selectively locking the insertion tip to the latching assembly. The latching assembly has an outer dimension that is changeable from an expanded state for locking the insertion tip to the latching assembly to a non-expanded state for unlocking the insertion tip from the latching assembly.
In spite of the above advances, there remains a need for additional delivery systems for implanting surgical mesh implants whereby the insertion aids used for advancing the surgical mesh through tissue may be removed from the patient after use.